pfizer: Aurobindo gets licence to make generic version of Pfizer’s oral antiviral Covid-19 pill nirmatrelvir | India News – Times of India
HYDERABAD: Pharma major Aurobindo Pharma Limited has inked a sub-license agreement with the UN-backed Medicines Patent Pool (MPP) for manufacturing and supplying a generic version of Pfizer’s Covid-19 oral treatment nirmatrelvir to 95 countries, including India.
MPP had earlier signed a voluntary licensing agreement with Pfizer to sub-licence this Covid-19 drug to qualified generic drugmakers.
Nirmatrelvir, in combination with ritonavir co-pack, has received emergency use or conditional authorization for Covid-19 treatment in certain populations by USFDA, the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) and about 50 other countries.
The Hyderabad-based pharma biggie said it has backward integration for nirmatrelvir and ritonavir molecules, like other antivirals, with in-house API manufacturing facilities that give it stronger control on the supply chain and cost efficiencies.
The generic version of Pfizer’s drug will be manufactured at the company’s manufacturing facilities in India that are approved by global regulatory agencies like USFDA and UKMHRA, the company said, adding that it has adequate capacities to meet the global demand for the drug across 95 countries, including India.
Commenting on the development, Aurobindo Pharma vice-chairman & managing director K Nithyananda Reddy said the company has already developed and commercialized ritonavir which is used as a booster along with nirmatrelvir. “We will soon make it available commercially at an affordable price for these (low & middle income) markets after due process of registration and approval in various countries, including applying to DCGI in India,” Reddy said.
Reddy said this combination will be a valuable addition to Aurobindo Pharma’s portfolio along with Molnupiravir for the treatment of Covid-19.
MPP had earlier signed a voluntary licensing agreement with Pfizer to sub-licence this Covid-19 drug to qualified generic drugmakers.
Nirmatrelvir, in combination with ritonavir co-pack, has received emergency use or conditional authorization for Covid-19 treatment in certain populations by USFDA, the UK Medicines and Healthcare products Regulatory Agency (UKMHRA) and about 50 other countries.
The Hyderabad-based pharma biggie said it has backward integration for nirmatrelvir and ritonavir molecules, like other antivirals, with in-house API manufacturing facilities that give it stronger control on the supply chain and cost efficiencies.
The generic version of Pfizer’s drug will be manufactured at the company’s manufacturing facilities in India that are approved by global regulatory agencies like USFDA and UKMHRA, the company said, adding that it has adequate capacities to meet the global demand for the drug across 95 countries, including India.
Commenting on the development, Aurobindo Pharma vice-chairman & managing director K Nithyananda Reddy said the company has already developed and commercialized ritonavir which is used as a booster along with nirmatrelvir. “We will soon make it available commercially at an affordable price for these (low & middle income) markets after due process of registration and approval in various countries, including applying to DCGI in India,” Reddy said.
Reddy said this combination will be a valuable addition to Aurobindo Pharma’s portfolio along with Molnupiravir for the treatment of Covid-19.
